Effectiveness of the blanket model of light emitting diode BLUI blanket” phototherapy on decreasing serum bilirubin levels in physiological jaundice at gestational age = 35 weeks

Phase 3

• Conditions: eonatal jaundice; Pregnancy and Childbirth

• Registration Number: ISRCTN17473621
• Lead Sponsor: embaga Pengelola Dana Pendidikan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-06
• Last Update Posted: 20 June 2023
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Infants with gestational age = 35 weeks and birth weight = 2000 grams (p25)
2. Postnatal age > 24 hours – 14 days
3. No history of birth trauma/cephalhematoma/bleeding
4. Total serum bilirubin levels are 10 and less than19 mg/dl (cut-off value for medium risk infants, gestational age 35-36 6/7 weeks and fit), and radar serum bilirubin total 12 less 22 mg/dl (limit value lower risk infants aged = 38 weeks and fit)
5. Asian race
6. No circulatory disturbances, respiratory disorders, and saturation above 90%
7. The patient's parents/guardians agree to participate in the study and sign an informed consent

Exclusion Criteria

1. Genetic, metabolic disorders, hemolytic anemia (examination of GDS levels, blood group, and rhesus, peripheral blood picture)
2. Infection (clinical fever or hypothermia and increased leukocyte laboratory tests)
3. The direct bilirubin level exceeds 2 mg/dl or 20% of the total serum bilirubin level

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bilirubin serum level measured by examination of blood serum at 24 hours after the start of phototherapy

Secondary Outcome Measures

Name	Time	Method
Side effects measured by physical examination at 24 hours after the start of phototherapy